Obstetric Anal Sphincter InjuryCArE for OAsINCT06143072
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
An observational study of Obstetric Anal Sphincter Injury and Severe Perineal Trauma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: There are two parts to study: Part 1: semi-structured interview, retrospective study, mix of qualitative and quantitative methods - involving patients. Women who have sustained an obstetric-related anal sphincter injury (grade 3 and 4 perineal tears) AND who are symptomatic of anal/faecal incontinence within the first five years following a vaginal delivery are eligible to participate, provided they have capacity to consent. Part 2: Cross-sectional, observational study with a mix of qualitative and quantitative analysis, using a survey, to be completed by urogynaecologists/obstetricians Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK.
Who may be able to join
- • Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence following a vaginal delivery in the preceding five years (N.B. the average age of menopause in the UK is 51)
- Tertiary referrals to the specialist perineal clinic as well as patients who have 'slipped' through the existing pathway of referral
- Capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher)
- English-speaking and able to comprehend and read English
- Primiparous/multi-parous
- urogynaecologists/obstetricians who oversee the care of or look after patients with OASI and who are practising in UK NHS hospitals at the time of completion of the survey. They must be on the GMC specialist register to be eligible to participate
Who cannot join
- • Women who are unable to consent or who have severe mental illness, as decided by the screening clinician
- Patients who do not speak, read or understand English
- Patients with an alternative documented cause for their FI that is non obstetric trauma related.
- Post-menopausal women who may develop late onset symptoms of incontinence relating to a previous OASI (clinically silent injuries that manifest in later life secondary to hormonal influences or advancing age for example).
- Women with an OASI who have been referred directly from the maternity unit at the same trust as the specialist perineal clinic, where an existing trust policy exists for direct referral of these patients from the maternity unit to the perineal clinic.
- Part 2 of study:
- trainees, obstetricians/gynaecologists not routinely involved in the care of OASI patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
London Northwest Healthcare NHS Trust
London, NW10 7NS
Sunder Chita, 02088695829, sunderchita@nhs.net
About this study
Official title: Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision.
As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.
Read the detailed description
Historically, pregnancy and childbirth has been erroneously considered to be an innocuous physiological event. However, vaginal delivery may be associated with perineal injury, a common occurrence affecting up to 80% of women. Perineal injury is classified into four categories, as per the Sultan classification:
Grade 1: involvement of perineal skin +/- vaginal mucosa Grade 2: involvement of perineal muscles Grade 3a: <50% External Anal Sphincter (EAS) Grade 3b: >50% EAS Grade 3c: EAS + Internal Anal Sphincter (IAS) Grade 4: Grade 3c + anorectal mucosa The latter two categories are associated with considerable morbidity and are known as obstetric anal sphincter injuries (OASIS). OASIS encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa.
Such injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse, which in turn may have a negative impact on a woman's quality of life and day-to-day living. Indeed, sustaining an Obstetric Anal Sphincter Injury (OASI) has been associated with both physical and psychological sequelae.
Symptoms of urgency and urge faecal incontinence, are suggestive of damage to the external anal sphincter, while symptoms of passive leakage are indicative of damage to the internal anal sphincter. Not all women with OASIS are symptomatic. Symptomatic OASIS occurs in about 30-50% of women. It is important to note that the real incidence may be higher as it may very well be underreported.
The incidence of OASIS in the UK is 2.9%. Although OASIS is uncommon, the rate of OASIS in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising OASI rates, the OASI care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of OASIS. Prevention of OASIS, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients' post-partum.
The RCOG (royal college of obstetricians and gynaecologists) guidance states that clinicians should diagnose an OASI at the time of delivery by meticulous inspection of the perineum, which should include a digital rectal examination. Referral to a colorectal specialist should be considered in those who are symptomatic of incontinence. However, in the absence of a standardised national pathway, the provision of healthcare appears to rely heavily on the availability of resources, a clinician's discretion and ultimately a 'postcode lottery'. Indeed, while some trusts may have the necessary provisions in place to support mothers with OASIS, in other areas, women may be left to fend for themselves.
Moreover, the stigma and shame associated with sustaining such an injury may perpetuate the difficulty in seeking medical attention, even in the most motivated patients, thereby producing a population of silent sufferers, who are stuck in a pervasive pattern of shame, embarrassment and inevitably, melancholy.
There may also be the erroneous belief among healthcare professionals, that these symptoms would settle on their own and this may be communicated to the afflicted individual who may be reassured by this information. Although 60-80% of women are asymptomatic at one year, some remain symptomatic, with devastating consequences on their quality of life. Further, patients with an asymptomatic injury ought to be counselled regarding the risk of incontinence in later life, secondary to advancing age and hormonal influence on pelvic floor function as well as the added impact of future deliveries. When discussing mode of delivery for future pregnancies, it should be highlighted that although an elective caesarean section may protect against an anal sphincter injury, it may not prevent pudendal neuropathy which may also contribute to symptoms of incontinence.
- Conditions
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear, Anal Incontinence, Faecal Incontinence
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 of study | Women who have sustained an obstetric-related anal sphincter injury (grade 3 and 4 perineal tears) AND who are symptomatic of anal/faecal incontinence within the first five years following a vaginal delivery are eligible to participate, provided they have capacity to consent. | |
| Part 2 of study | Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
considering whether the patient was assessed clinically for incontinence during the post-partum check at 6-12 weeks conducted by the obstetrics/urogynaecology team (part 1 of study)
Measured: 12 months
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
considering the ease with which they were able to discuss the symptoms of incontinence with a clinician (part 1 of study)
Measured: 12 months
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
considering how symptoms were managed before consulting a clinician and after (part 1 of study)
Measured: 12 months
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
considering who they saw during their follow up appointments and when (including referrals), and what was discussed and what action was taken for the management of their incontinence (including counselling regarding future pregnancies) (part 1 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
considering whether the patient was assessed clinically for incontinence during the post-partum check at 6-12 weeks as conducted by the team (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
considering how these patients are assessed (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
considering the length of time taken to follow up a patient (whether symptomatic or asymptomatic) (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
considering if there is a policy/pathway in place for the management of OASI-associated incontinence (part 2 of study)
Measured: 12 months
Secondary outcomes (5)
Degree of OASI in relation to symptoms and Quality of Life, evaluated using a patient's own verbatim account of their lived experience and assessed via open ended questions in a semi-structured interview.
The influence of severity of OASI on incontinence, and the latter's effect on the patient's quality of life (including effect on job, family and relationships) (part 1 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
considering: whether or not these patients are discussed in the MDT (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
considering whether or not these patients are reviewed by a physiotherapist and if so, at what stage post-partum? (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
considering: If they are referred for anorectal studies (part 2 of study)
Measured: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
considering whether or not these patients are referred for biofeedback and if not, why. (part 2 of study)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143072
- Sponsor's protocol ID
- 333989
- Acronym
- CArE for OAsI
- Status last verified
- May 2025
- First submitted
- 6 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery
- ClinicalTrials.gov ID
- NCT06143072
- Acronym / sponsor ID
- CArE for OAsI / 333989
- Conditions
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear, Anal Incontinence, Faecal Incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision.
As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.
Detailed description
Historically, pregnancy and childbirth has been erroneously considered to be an innocuous physiological event. However, vaginal delivery may be associated with perineal injury, a common occurrence affecting up to 80% of women. Perineal injury is classified into four categories, as per the Sultan classification:
Grade 1: involvement of perineal skin +/- vaginal mucosa Grade 2: involvement of perineal muscles Grade 3a: <50% External Anal Sphincter (EAS) Grade 3b: >50% EAS Grade 3c: EAS + Internal Anal Sphincter (IAS) Grade 4: Grade 3c + anorectal mucosa The latter two categories are associated with considerable morbidity and are known as obstetric anal sphincter injuries (OASIS). OASIS encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa.
Such injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse, which in turn may have a negative impact on a woman's quality of life and day-to-day living. Indeed, sustaining an Obstetric Anal Sphincter Injury (OASI) has been associated with both physical and psychological sequelae.
Symptoms of urgency and urge faecal incontinence, are suggestive of damage to the external anal sphincter, while symptoms of passive leakage are indicative of damage to the internal anal sphincter. Not all women with OASIS are symptomatic. Symptomatic OASIS occurs in about 30-50% of women. It is important to note that the real incidence may be higher as it may very well be underreported.
The incidence of OASIS in the UK is 2.9%. Although OASIS is uncommon, the rate of OASIS in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising OASI rates, the OASI care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of OASIS. Prevention of OASIS, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients' post-partum.
The RCOG (royal college of obstetricians and gynaecologists) guidance states that clinicians should diagnose an OASI at the time of delivery by meticulous inspection of the perineum, which should include a digital rectal examination. Referral to a colorectal specialist should be considered in those who are symptomatic of incontinence. However, in the absence of a standardised national pathway, the provision of healthcare appears to rely heavily on the availability of resources, a clinician's discretion and ultimately a 'postcode lottery'. Indeed, while some trusts may have the necessary provisions in place to support mothers with OASIS, in other areas, women may be left to fend for themselves.
Moreover, the stigma and shame associated with sustaining such an injury may perpetuate the difficulty in seeking medical attention, even in the most motivated patients, thereby producing a population of silent sufferers, who are stuck in a pervasive pattern of shame, embarrassment and inevitably, melancholy.
There may also be the erroneous belief among healthcare professionals, that these symptoms would settle on their own and this may be communicated to the afflicted individual who may be reassured by this information. Although 60-80% of women are asymptomatic at one year, some remain symptomatic, with devastating consequences on their quality of life. Further, patients with an asymptomatic injury ought to be counselled regarding the risk of incontinence in later life, secondary to advancing age and hormonal influence on pelvic floor function as well as the added impact of future deliveries. When discussing mode of delivery for future pregnancies, it should be highlighted that although an elective caesarean section may protect against an anal sphincter injury, it may not prevent pudendal neuropathy which may also contribute to symptoms of incontinence.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 of study | – | –Women who have sustained an obstetric-related anal sphincter injury (grade 3 and 4 perineal tears) AND who are symptomatic of anal/faecal incontinence within the first five years following a vaginal delivery are eligible to participate, provided they have capacity to consent. |
| Part 2 of study | – | –Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- There are two parts to study: Part 1: semi-structured interview, retrospective study, mix of qualitative and quantitative methods - involving patients. Women who have sustained an obstetric-related anal sphincter injury (grade 3 and 4 perineal tears) AND who are symptomatic of anal/faecal incontinence within the first five years following a vaginal delivery are eligible to participate, provided they have capacity to consent. Part 2: Cross-sectional, observational study with a mix of qualitative and quantitative analysis, using a survey, to be completed by urogynaecologists/obstetricians Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK.
Key inclusion criteria (6 listed)
- • Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence following a vaginal delivery in the preceding five years (N.B. the average age of menopause in the UK is 51)
- urogynaecologists/obstetricians who oversee the care of or look after patients with OASI and who are practising in UK NHS hospitals at the time of completion of the survey. They must be on the GMC specialist register to be eligible to participate
Key exclusion criteria (7 listed)
- • Women who are unable to consent or who have severe mental illness, as decided by the screening clinician
- trainees, obstetricians/gynaecologists not routinely involved in the care of OASI patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering whether the patient was assessed clinically for incontinence during the post-partum check at 6-12 weeks conducted by the obstetrics/urogynaecology team (part 1 of study)
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering the ease with which they were able to discuss the symptoms of incontinence with a clinician (part 1 of study)
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering how symptoms were managed before consulting a clinician and after (part 1 of study)
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering who they saw during their follow up appointments and when (including referrals), and what was discussed and what action was taken for the management of their incontinence (including counselling regarding future pregnancies) (part 1 of study)
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering whether the patient was assessed clinically for incontinence during the post-partum check at 6-12 weeks as conducted by the team (part 2 of study)
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering how these patients are assessed (part 2 of study)
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering the length of time taken to follow up a patient (whether symptomatic or asymptomatic) (part 2 of study)
The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care
Time frame: 12 months
considering if there is a policy/pathway in place for the management of OASI-associated incontinence (part 2 of study)
5 secondary outcomes
Degree of OASI in relation to symptoms and Quality of Life, evaluated using a patient's own verbatim account of their lived experience and assessed via open ended questions in a semi-structured interview.
Time frame: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
Time frame: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
Time frame: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
Time frame: 12 months
The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anal Sphincter Injury and Severe Perineal Trauma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.